Lower Extremity Intermittent Negative Pressure for Intermittent Claudication. Follow-Up after 24 Weeks of Treatment

Henrik Hoel; Erik Mulder Pettersen; Lars Øivind Høiseth; Iacob Mathiesen; Arne Seternes; Jonny Hisdal

doi:10.1016/j.avsg.2021.03.016

Lower Extremity Intermittent Negative Pressure for Intermittent Claudication. Follow-Up after 24 Weeks of Treatment

Ann Vasc Surg. 2021 Aug:75:253-258. doi: 10.1016/j.avsg.2021.03.016. Epub 2021 Apr 4.

Authors

Henrik Hoel¹, Erik Mulder Pettersen², Lars Øivind Høiseth³, Iacob Mathiesen⁴, Arne Seternes⁵, Jonny Hisdal⁶

Affiliations

¹ Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway; Department of Vascular Surgery, Oslo University Hospital, Oslo, Norway; Otivio AS, Oslo, Norway. Electronic address: ho-hen@online.no.
² Department of Surgery, Sørlandet Hospital, Kristiansand, Norway; Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.
³ Department of Anesthesiology, Oslo University Hospital, Oslo, Norway.
⁴ Otivio AS, Oslo, Norway.
⁵ Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Section for Vascular Surgery, Department of Surgery, St. Olavs Hospital, Trondheim, Norway.
⁶ Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway; Department of Vascular Surgery, Oslo University Hospital, Oslo, Norway.

PMID: 33823265
DOI: 10.1016/j.avsg.2021.03.016

Abstract

Background: Treatment with lower extremity intermittent negative pressure (INP) of -40 mm Hg for one hour twice daily for 12 weeks, increases walking capacity in patients with intermittent claudication (IC). However, the effects of INP treatment beyond 12 weeks have not been elucidated. The aim of the present study was to investigate the clinical effects of INP treatment after 24 weeks in patients with IC.

Methods: This was a follow-up study after a randomized sham-controlled trial, where patients randomized to the active treatment group were offered to continue treatment for 12 additional weeks (24 weeks in total). Treatment with -40 mm Hg INP was applied in a pressure chamber sealed around the lower leg, and the patients were instructed to treat themselves at home one hour in the morning and one hour in the evening. Pain free walking distance (PWD), maximal walking distance (MWD), resting ankle-brachial index (ABI) and post exercise ABI were measured at baseline, after 12 and 24 weeks.

Results: Ten out of 32 patients (31%) from the active treatment group in the initial trial were included in this follow-up study. At baseline, PWD was (mean ±SD) 151 ± 91 m and MWD was 362 ±159 m. There was a significant increase in both PWD and MWD after 24 weeks of treatment, compared to baseline (ANOVA; P= 0.006 and P= 0.012, respectively). Post hoc tests revealed that PWD increased significantly from baseline to 12 weeks (mean 81 m; 95% CI [6, 156]; P = 0.032), and that MWD increased significantly from 12 to 24 weeks (mean 145 m; 95% CI [22, 268]; P = 0.018). There were no significant changes in resting ABI or post exercise ABI during the 24-week treatment period (ANOVA; P= 0.157 and P= 0.450, respectively).

Conclusion: Both PWD and MWD improved after treatment with - 40 mm Hg INP for one hour twice daily for 24 weeks, compared to baseline. The main improvement in PWD occurred during the first 12 weeks of treatment, whereas the main improvement in MWD occurred between 12 and 24 weeks of treatment.

Keywords: Peripheral artery disease; intermittent claudication; lower extremity intermittent negative pressure treatment.

Publication types

Randomized Controlled Trial

MeSH terms

Aged
Ankle Brachial Index
Exercise Tolerance
Female
Follow-Up Studies
Humans
Intermittent Claudication / diagnosis
Intermittent Claudication / physiopathology
Intermittent Claudication / therapy*
Lower Body Negative Pressure* / adverse effects
Lower Extremity / blood supply*
Male
Middle Aged
Peripheral Arterial Disease / diagnosis
Peripheral Arterial Disease / physiopathology
Peripheral Arterial Disease / therapy*
Recovery of Function
Time Factors
Treatment Outcome
Walk Test
Walking